Director, Clinical Operations
Daiichi Sankyo
- Basking Ridge, NJ
- Permanent
- Full-time
- Operational Strategy
When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.
Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo’s quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk related plans and ensure study team adherence and utilization. Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly. * People and Resource ManagementResponsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalfQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
- Bachelor's Degree in the Sciences preferred
- 10 or More Years relevant experience required
- 4 or More Years with a MS/MPH preferred
- 4 or More Years with PharmD/PhD preferred
- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
- CRA experience preferred
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred